Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02409862
Status:
WITHDRAWN
Last Update Posted:
2018-11-26
First Post:
2015-03-12
Brief Title:
Faces Choices Study
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Faces Choices Study
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Technical issues preventing recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The neuropeptide oxytocin OXT originally known for its role in inducing uterine contractions has been shown to be involved in many of the social capacities that seem to change with age such as emotion detection and identification enhanced social memory empathy and trust Thus age-related changes in the OXT system may underlie differences between young and older adults in socioemotional functioning Research on the effects of oxytocin in aging is very scarce therefore the purpose of this research project is to determine the effects of oxytocin on socioemotional aging The aim of this research is to examine the behavioral and neural effects of OXT on decisions of trust in social interactions perceptions of facial trustworthiness the ability to read faces and levels of empathy with other people in samples of young and older adults
Detailed Description:
Overview This study has three parts An initial screening visit and two study visits All visits to be conducted at the Institute on Aging at the University of Florida
Screening Visit - Screening Together with the information obtained in the phone screening the main purpose of the screening visit is to find out if the participants are eligible to participate in the study
One of the investigators trained researchers will ask the participant questions about their health condition and recent activities
The participant will be given instructions and assistance in the collection of saliva to determine the baseline level of cortisol in their body
A trained researcher will then ask the participant questions about their personality and experiences in close relationships
The participant will then be asked to provide the second saliva sample to find out how the activity of their genes may impact their cognition and behavior during the tasks they engage in as part of the study
The researcher will then conduct two cognitive tests Digit Substitution Task Verbal Learning Test
This will be followed by a blood test to screen for medical conditions that may indicate that the participant should not participate in the study such as certain blood levels elevated out of normal range The blood test will also be used to determine the level of oxytocin testosterone and estrogen in the participants body that occur normally
The participant will then have a brief consultation with a licensed physician to go over their medical review This will not be a clinical doctor visit for routine medical care but a visit to confirm the participants healthy medical status to participate in the research study
Study Visits -
A researcher will ask the participant to answer a short questionnaire comprising questions about activities and events during the last 24 hours
A researcher will ask for the participant to respond to a short questionnaire related to their current mood
The participant will be asked to provide a first saliva sample to determine the baseline level of oxytocin in their body on the day of testing
The participant will be asked to self-administer either the oxytocin or a placebo into their nose by using a nasal spray bottle Oxytocin is a hormone that naturally occurs in the body and has been shown to be relevant for many behaviors especially in social situations The participant will be assigned by chance much like the flip of a coin to receive either the oxytocin or the placebo during the first study visit The participant will then receive the other during the second study visit respectively
The participant will then be asked to participate in an electroencephalography EEG recording session that is recording of electrical activity along their scalp An EEG cap selected for the participants head size will be placed on their head During this part of the study the participant will sit in a comfortable chair while working on the Choice Task on the computer screen or resting
While recording EEG the participants eye movements will be monitored with an eye tracker The eye-tracking camera will be placed so that it can capture the participants eyes and after a brief calibration procedure will track the participants eye movements while working on the task or resting
The Choice Task will involve making decisions that involve the participant as well as a fellow player Before the task starts the participant will receive detailed information and have a chance to ask any questions that they may have about the task or about the EEG and eye tracking procedures They will also have the chance to work on some practice trials
Next the participant will be asked to provide a second saliva sample to determine the level of oxytocin in their body after they have received the oxytocin or placebo and some time has passed
After the Choice Task the participant will complete a few more questionnaires including questions about feelings and thoughts about themselves and others and questions about how they completed the Choice Task and whether they experienced any drug side effects or any discomfort during the EEG or eye tracking
The second study visit will take place about a week after the first study visit and will be identical in procedure
Both visits will be followed up by a brief phone call from a researcher about 3 days after the study visit
Upon completion of the study the participant will receive study reimbursement A researcher will tell the participant about the general goals of the study and answer any questions that they may have
Screening Visit - Screening Together with the information obtained in the phone screening the main purpose of the screening visit is to find out if the participants are eligible to participate in the study
One of the investigators trained researchers will ask the participant questions about their health condition and recent activities
The participant will be given instructions and assistance in the collection of saliva to determine the baseline level of cortisol in their body
A trained researcher will then ask the participant questions about their personality and experiences in close relationships
The participant will then be asked to provide the second saliva sample to find out how the activity of their genes may impact their cognition and behavior during the tasks they engage in as part of the study
The researcher will then conduct two cognitive tests Digit Substitution Task Verbal Learning Test
This will be followed by a blood test to screen for medical conditions that may indicate that the participant should not participate in the study such as certain blood levels elevated out of normal range The blood test will also be used to determine the level of oxytocin testosterone and estrogen in the participants body that occur normally
The participant will then have a brief consultation with a licensed physician to go over their medical review This will not be a clinical doctor visit for routine medical care but a visit to confirm the participants healthy medical status to participate in the research study
Study Visits -
A researcher will ask the participant to answer a short questionnaire comprising questions about activities and events during the last 24 hours
A researcher will ask for the participant to respond to a short questionnaire related to their current mood
The participant will be asked to provide a first saliva sample to determine the baseline level of oxytocin in their body on the day of testing
The participant will be asked to self-administer either the oxytocin or a placebo into their nose by using a nasal spray bottle Oxytocin is a hormone that naturally occurs in the body and has been shown to be relevant for many behaviors especially in social situations The participant will be assigned by chance much like the flip of a coin to receive either the oxytocin or the placebo during the first study visit The participant will then receive the other during the second study visit respectively
The participant will then be asked to participate in an electroencephalography EEG recording session that is recording of electrical activity along their scalp An EEG cap selected for the participants head size will be placed on their head During this part of the study the participant will sit in a comfortable chair while working on the Choice Task on the computer screen or resting
While recording EEG the participants eye movements will be monitored with an eye tracker The eye-tracking camera will be placed so that it can capture the participants eyes and after a brief calibration procedure will track the participants eye movements while working on the task or resting
The Choice Task will involve making decisions that involve the participant as well as a fellow player Before the task starts the participant will receive detailed information and have a chance to ask any questions that they may have about the task or about the EEG and eye tracking procedures They will also have the chance to work on some practice trials
Next the participant will be asked to provide a second saliva sample to determine the level of oxytocin in their body after they have received the oxytocin or placebo and some time has passed
After the Choice Task the participant will complete a few more questionnaires including questions about feelings and thoughts about themselves and others and questions about how they completed the Choice Task and whether they experienced any drug side effects or any discomfort during the EEG or eye tracking
The second study visit will take place about a week after the first study visit and will be identical in procedure
Both visits will be followed up by a brief phone call from a researcher about 3 days after the study visit
Upon completion of the study the participant will receive study reimbursement A researcher will tell the participant about the general goals of the study and answer any questions that they may have
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 39-2013 SubStudy | OTHER | University of Florida | None |